Trial Information

ANRS HIV CONTROLLERS NATIONAL OBSERVATORY

To study the virological and immunological features of these patients, a consortium of
research teams has been set up. Several results were obtained (cf publications) : HIC are
infected with replication-competent virus, HIV infects HIC CD4 T cells ex vivo but the CD8 T
cells fully control this viral replication. This study led to set up a national observatory
of the HICs. This observatory, set up from May 2006 to May 2008, has allowed to identify and
include 86 HIC patients in France (about one hundred had been reported by the ANRS centers).
When a patient is included, clinical data are collected and a biologic collection set up
which can be used in genomic studies. The main characteristics of the patients included in
the observatory are a median age at the diagnosis of HIV infection of 29 years (range 1-49),
a median age at inclusion of 45 years [19-78], 42% are women, 87% are caucasians. The median
year of HIV diagnosis is 1989 (1983-1999), so a median of 18 years of known HIV infection.
The CD4 median between 1986 and 2008 is 762 CD4/mm3 [IQR:589-962], 3% of the 1368 measures
are ≤ 350 /mm3; 23% patients have a CD4 T cell count < 500/mm3 and 6% < 350/mm3 at the
inclusion consultation. The CD4 slope on this period shows a slow decrease estimated to -13
[-15,-11] CD4/mm3 per year. Between 1989 and 2007, 2% of the viral loads measured were ≥
1000 RNA copies/mL. The viral load at inclusion is > 400 RNA copies/mL in 4%. Median viral
DNA at the inclusion in the observatory is 1, 75 [1, 44-2, 07] log copies/millions PBMC.

The transformation of the observatory in a cohort CO 18 has several goals. The first one is
to allow the long-term follow-up of the HIV controllers. Epidemiological, clinical,
virological, and immunological data will be collected. The outcome of these patients is a
major question: some patients could loose their HIC status either because of a drop in their
CD4 T cell counts to a level below 200/mm3 without major viral replication or because viral
replication becomes detectable. To understand the mechanisms involved in the control of the
viral replication in HIC implies to study the patients in whom the viral control is lost and
to compare them to the HIC in whom the control is preserved. Therefore it is of major
importance to follow the patients now included in the observatory during a prolonged time.
To increase the frequency of loss of control, the patients in whom the virus is controlled
for at least 5 years but for less than 10 years will be included to increase the diversity
of the HICs. Clinical events as neoplasias will be collected. The genomic studies will be
continued with the benefits of new inclusions and european collaborations will be developed.
The question of the quality-of-life of the patients HIC will be studied.